Circular stapler buttress

ABSTRACT

A buttress for use with circular surgical staplers that does not require adhesive to securely fasten the buttress to the stapler. Following cutting and stapling by the circular stapler, the buttress has an adaptive opening through its central region with a diameter smaller than the outer diameter of the stapler anvil. Because of relief features built into the buttress, the stapler anvil may be pulled through the buttress material without causing permanent alteration to the buttress. These relief features may be provided regardless of whether the buttress is made of inelastic or elastic materials. The buttress is generally circular in shape with an outer diameter sized to coincide with the outer diameter of the stapler body staple compression surface and the outer diameter of the anvil compression surface of a circular stapler with which it is used. Prior to surgical use, the buttress is attached to the stapler with disruptable portions extending from outer perimetal areas of the buttress.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of co-pending applicationSer. No. 10/666,204, filed Sep. 17, 2003.

FIELD OF THE INVENTION

The present invention relates to the field of surgical buttresses.

BACKGROUND OF THE INVENTION

A circular stapler is one device that can be used in surgicalapplications for the joining of body tissue. In the area of surgicalanastomotic stapling, it can be used for joining pieces of tissue in amanner such that a continuous pathway, lumen, or surgical opening, isformed after the tissue is stapled together. This lumen is formed when acircle of staples is used to join two pieces of tissue after which thetissue interior to the innermost circle of staples is cut out by aconcentric circular retractable blade. Retraction of the circularstapler removes the cut tissue to form a lumen. An example of a circularstapler is given in U.S. Pat. No. 5,104,025 to Main et al. Other devicesand methods can also be used to produce anastomoses.

When used in surgery for colorectal disorders the circular stapler isused to reform the colon into a continuous lumen after a section isremoved for treatment of the disease state. Concerns about leakage ofthe colon contents into the peritoneal cavity from the anastomosis siteare prevalent during this type of surgery. A complete seal between thepieces of tissue that are joined is desirable to prevent leakage.Another concern in colon resections is reduction of the lumen diameterafter surgery. This reduction in diameter would result in therestriction of the passage of biological material.

Using a stapler that forms a lumen with a diameter close to that of thepreoperative healthy colon is desirable to prevent these flowrestrictions. Typically the circle of staples formed is between 2-4 cmin diameter and is made from 20 to 40 small, metallic staples. Due inpart to the presence of these metallic staples, another concern intissue resection is tearing of the tissue at the anastomosis site.

Modifications to circular staplers as well as the development of otherdevices have been described to address the concerns that may occurduring stapling of body tissue and the formation of a tissueanastomosis. A device used to create an anastomosis without staples isdescribed in U.S. Pat. No. 5,222,963 to Brinkerhoff et al. and U.S. Pat.No. 5,250,058 to Miller et al. This device uses a tissue coupler madefrom a bioabsorbable polymer. A concern in using this device is the riskof tissue separation at the anastomosis site after the polymer has beenabsorbed by the body. A similar concern is shared for the devicedescribed in U.S. Pat. No. 5,346,501 to Regula et al., as it also usesonly a bioabsorbable material for the formation of the anastomosis.

To alleviate the concern about tissue separation after the absorption ofa bioabsorbable material, non-absorbable biocompatible metal staples canbe used to form the anastomosis. However, leakage and/or tearing at thesite where the tissue is joined are concerns when only metal staples areused. In order to prevent leakage and/or tearing, supporting buttressesconstructed of both non-bioabsorbable and bioabsorbable materials foruse with surgical staplers have been described in various publications.U.S. Pat. No. 6,503,257 to Grant et al. teaches a method for using anadhesive to releasably attach a buttress construct to a surgicalstapling instrument. This buttress addresses both the leakage and/ortearing concerns that occur during tissue stapling. The use of metalstaples provides for the long-term joining of the tissue. However, thebuttress must be carefully aligned onto the stapling instrument and asuitable adhesive must be used on the surfaces of both the buttress andthe stapling instrument to secure the buttress to the staplinginstrument. Further, withdrawing the anvil part of the stapler throughthe buttress may be difficult, as the inner diameter of the buttress issmaller than the outer diameter of the stapler anvil.

A potential concern about use of an adhesive substance applied to thebuttress is incompatibility of the adhesive with the tissue in thepatient that it contacts. One mode of this tissue contact may be betweenthe adhesive-containing surface of the buttress and tissue of thepatient in the area of the anastomotic junction. The adhesive may alsobe transferred onto the staple surfaces as they penetrate through theadhesive present on the buttress and may then be carried into the tissueof the patient. An alternative to using adhesive on the buttress wouldbe to design the buttress with protrusions that extend from theperimeter of the buttress and which may be provided with adhesive. Theseprotrusions could be used to securely fasten the buttress to thecircular stapler body and to the circular stapler anvil. Further, theseprotrusions could be disruptably attached, connected or fastened to thebuttress to allow the protrusions to separate from the buttress in acontrolled fashion.

SUMMARY OF THE INVENTION

The present invention is in the form of a buttress reinforcement devicefor use with circular surgical staplers that does not require anadhesive substance between the buttress and stapler to securely fastenthe buttress to the stapler. The present invention is designed withprotrusions that extend from the perimeter of the buttress and which maybe provided with adhesive. These protrusions are used to align andsecurely fasten the buttress to the circular stapler body and/or to thecircular stapler anvil. Further, these protrusions are disruptablyattached, connected, or fastened to the buttress allowing for separationof the protrusions from the buttress in a controlled fashion.

In a preferred embodiment, when used with a circular surgical stapler, ahole is cut in the central region of the buttress by the stapler'scircular cutting blade. The diameter of the hole formed in the buttressby the stapler's circular cutting blade is smaller than the outerdiameter of the stapler's anvil. Relief features built into the buttressallow the stapler anvil to pull through the hole created in the buttressby the stapler's circular cutting blade without causing substantialpermanent alteration to the buttress. These relief features can beprovided regardless of whether the buttress is made of inelastic orelastic materials.

The buttress can be generally circular in shape with an outer diametersized to coincide with the outer diameter of the stapler body staplecompression surface and the outer diameter of the anvil compressionsurface of a circular stapler with which it is used. Alternatively, thebuttress material may be formed into other non-circular geometric shapes(e.g. octagons). Also, the buttress material can be sized to be largerthan or the same as the outer diameter of the stapler body staplecompression surface and the outer diameter of the anvil compressionsurface of a circular stapler with which it is used in order to allowfor self-alignment. This self-alignment insures that the buttress isaligned to coincide with and cover the pattern of staples ejected fromthe stapler. The buttress may have a generally circular opening in itscentral region that is sized to closely fit the central shaft of acircular stapler with which it is used. Alternatively, the buttress mayhave slits or other openings cut in its central region to allow forfitting the buttress onto the central shaft of a circular stapler whileretaining the self-alignment feature. In a preferred embodiment, thecentral region of the buttress is that area which is cut away from thebuttress by the action of the stapler cutting blade. In addition to thecentral opening, the buttress may have a slit or other opening reachingfrom the central opening to the outer diameter of the buttress. Thisfeature would allow the buttress to be placed onto the central shaft ofa circular stapler even when the stapler anvil was already attached tothe stapler body through the central shaft.

In one embodiment, the buttress can have a retaining ring, disk, orsimilar device within or around its central region with a centralopening. This retaining ring, disk, or similar device can be used to aidin the retention of the buttress onto the central shaft of the circularstapler without requiring the use of an adhesive substance between thecentral shaft of the stapler and the buttress construct. The retentionof the buttress onto the circular stapler allows for movement, removal,or repositioning of the circular stapler during operation without lossor displacement of the buttress from the stapler.

In a preferred embodiment, the buttress is provided with removable ordisruptably connected protrusions extending from the outer perimeter ofthe buttress body. These protrusions are designed to conform to thecircular stapler body and/or the circular stapler anvil head so thatwhen folded, one side of each protrusion contacts the body of thecircular stapler and/or the circular stapler anvil head. Further, theprotrusions are provided with an adhesive on the side of the protrusionthat contacts the circular stapler body and/or circular stapler anvilhead so that when the protrusion is conformed to contact the body of thecircular stapler and/or circular stapler anvil head the buttress issecurely attached with the adhesive. The protrusions are renderedremovable from the buttress with a disruptable feature placedtherebetween. Examples of disruptable features can include a series ofholes, perforations, weakened sections or other means to allow for thecontrolled separation between the buttress and the protrusions. Analternate means of producing a weakened section is making that sectionthinner in cross section than other parts of the buttress or protrusion.

A preferred bioabsorbable buttress is fabricated from a copolymer ofpoly(glycolide:trimethylene carbonate). The copolymer's polyglycolidecomponent is commonly abbreviated as PGA for poly(glycolic acid), thechemical byproduct to which it degrades after hydrolysis. Thepoly(trimethylene carbonate) component is commonly abbreviated as TMC,with the copolymer itself typically referred to as PGA:TMC andaccompanied with relative percentage composition by weight. A preferredembodiment of the buttress is made from a bioabsobable ABA triblockcopolymer of 67% PGA:33% TMC (w/w), formed into a non-woven web astaught by Hayes in U.S. Pat. Nos. 6,165,217 and 6,309,423. Otherfabrications, processes, and polymers can alternatively be used toproduce an elastic bioabsorbable buttress, such as using the polymersdescribed by Bezwada in U.S. Pat. Nos. 5,468,253 and 5,713,920. Whilethe primary constituent polymer can be alternatively blended with otherpolymers or active or inactive agents prior to fabrication, theresulting buttress can be imbibed, coated, or otherwise loaded withtherapeutic or other either bioactive or bioinactive materials.

Accordingly, one embodiment of the present invention is a reinforcementdevice for use with a circular stapler that is adapted to create andseal a surgical opening in a patient comprising a buttress adapted formounting on the circular stapler, the stapler having an anvil that islarger in diameter than the surgical opening that is created by thestapler, wherein following stapling with the stapler, the buttressreinforces the surgical opening created by the stapler in the patient,wherein the buttress includes at least one adaptive opening created bythe circular stapler which corresponds to the surgical opening in thepatient, said adaptive opening when circular having a diameter smallerthan the diameter of the anvil, and wherein the adaptive opening in thebuttress allows the anvil to be removed therethrough without causingpermanent alteration to the buttress.

Another embodiment of the present invention is a reinforcement devicefor use with a circular stapler adapted to create a substantiallycircular hole in a patient, said circular stapler having a stapler anvilportion with a first compression surface and a stapler body portion witha second compression surface, said reinforcement device comprising afirst buttress having a first contact surface adapted to attach to saidstapler anvil without use of an adhesive on said first compressionsurface and said first contact surface, a second buttress having asecond contact surface adapted to attach to said stapler body withoutuse of an adhesive on said second compression surface and said secondcontact surface, and wherein the first and second buttresses reinforcesaid hole created by said stapler in said patient when staples areapplied.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are perspective views of the bioabsorbable circularstapler buttresses mounted on a typical circular stapler and showing howthe anvil portion of the circular stapler can be separated from the bodyof the stapler.

FIGS. 2A-2D are cross sectional views of colon undergoing resectionusing the buttresses of the present invention.

FIG. 2E is a perspective view of a longitudinal section of a colonundergoing resection using buttress of the present invention, that hasbeen cut and stapled by a circular stapler.

FIGS. 3A-3F show top views of various embodiments of the buttress.

FIGS. 3G, 3H, 3J and 3K show perspective views of the buttress havingvarious corrugations.

FIGS. 4A-4C show side views of three alternate embodiments of thebuttress with varying thicknesses and densities.

FIGS. 5A-5E show top views of elastic and inelastic buttresses prior toand following central region cut out by the generally circularconcentric cutting blade of a circular stapler and following removal ofthe anvil portion of a circular stapler through the central region hole.

FIG. 5G shows a cross sectional view of an inelastic buttress followingremoval of the anvil portion of a circular stapler though the holecreated by the generally circular concentric cutting blade of a circularstapler.

FIG. 6A shows a perspective view of a buttress allowing forself-alignment on the central shaft of a circular stapler.

FIG. 6B shows a cross sectional view of a buttress allowing forself-alignment on the central shaft of a circular stapler.

FIG. 6C shows a perspective view of a buttress allowing forself-alignment on the outer diameter of a stapler anvil head or staplerbody compression surface.

FIG. 6D shows a cross sectional view of a buttress allowing forself-alignment on the outer diameter of a stapler anvil head or staplerbody compression surface.

FIG. 7A shows a perspective view of a buttress with removableprotrusions extending from the perimeter of the buttress.

FIG. 7B shows a top view of a buttress with removable protrusionsextending from the perimeter of the buttress with one removable coveringremoved.

FIG. 7C shows a cross-sectional view of a buttress with removableprotrusions extending from the perimeter of the buttress.

FIG. 8A shows a front view of a circular stapler anvil head with abuttress in position to be attached with protrusions with removablecoverings removed from the protusions.

FIG. 8B shows a front view of a circular stapler body with a buttressattached using protrusions.

FIG. 9A shows a top view of a first laser cutting pattern that was usedto form a preferred embodiment of the device of the present invention.

FIG. 9B shows a top view of a second laser cutting pattern that was usedto form a preferred embodiment of the device of the present invention.

FIG. 9C shows a perspective view of a device of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a typical circular surgical stapler 10with two stapler buttresses 12 mounted on the central shaft 14 of thestapler. The stapler has an anvil head 16 with a staple compressionsurface 18. The anvil head 16 is removably attached to the stapler body22 via the central shaft 14 as shown in FIG. 1B. The stapler body alsohas a compression surface 20 through which staples are ejected.

A first buttress 12 has a first surface 17 adapted to contact the anvilhead staple compression surface 18. A second buttress 12 similarly has asecond surface 17A adapted to contact the stapler body compressionsurface 20. Contact surfaces 17 and 17A are without adhesive. Thecentral openings 15 in the buttresses 12 are sized to closely fit overthe central shaft 14 so that the buttresses self-align onto the shaft.The central openings 15 in the buttresses 12 may be generally circular,slits or of any other geometric shape. Because of the size and shape ofthe central openings 15, the buttresses 12 are self-aligned andconcentric to the cutting mechanism and stapler compression surfaces ofthe circular stapler. Each buttress 12 further has a member 13 that aidsin attaching the buttresses 12 to the central shaft 14 of the staplerwithout the use of adhesive substance between the central shaft 14 ofthe stapler and the buttresses 12. The buttresses 12 can be placed ontothe central shaft 14 of the circular stapler 10 when the stapler anvil16 is separated from the stapler body 22 as shown in FIG. 1B.Alternatively, a buttress 12 with a slit or other opening reaching fromthe central opening to the outer diameter of the buttress can be placedonto the central shaft 14 of a circular stapler 10 when the stapleranvil 16 is connected to the stapler body 22 as shown in FIG. 1A.

FIGS. 2A-2E show circular stapler buttresses 12 in use during, forexample, a typical colon resection. FIG. 2A shows the stapler anvil head16 and a buttress 12 placed inside the proximal end of a colon section24, wherein proximal is defined as being closer to the heart of thepatient being operated upon. An end of the central shaft 14 isprotruding through a hole 29 formed in the colon tissue wall 25. Thestapler body 22 and another buttress 12 are placed transanally inside adistal segment of the colon 26, wherein distal is defined as beingfarther from the heart of the patient being operated upon. Another endof the central tubular shaft 14 protrudes through a hole 31 formed inthe distal colon tissue wall 27.

FIG. 2B shows the central shaft 14 with the anvil head 16 now joined tothe stapler body 22. One buttress 12 is located between anvilcompression surface 18 and the proximal colon tissue wall 25. Anotherbuttress 12 is located between the body compression surface 20 and thedistal colon tissue wall 27. The circular stapler 10 can be operated soas to pull the anvil head 16 towards the stapler body 22 so that theanvil head 16 and stapler body 22 are moved to within close oppositionof each other.

FIG. 2C shows the anvil head 16 and stapler body 22 in close proximityto each other in a position where the staples can be ejected through thecompression surface on the stapler body 20 to pierce through theopposing tissue walls of both the proximal 25 and distal 27 colon wallsections and also though the buttresses 12 placed internally within eachcolon section. The staples upon ejection are bent as they impact on thecompression surface 18 of the anvil head 16 and compression surface 20of the stapler body 22, to form a shape designed to tightly hold thecolon sections together. The staples pierce through the colon tissuewalls 25, 27 and the buttresses 12 that are placed internally on eachside of the joined colon sections. FIG. 2C also shows a generallycircular concentric cutting blade 33 which can be actuated by thestapler operator when the stapler anvil head 16 has been moved to aposition of close opposition to the stapler body 22. The generallycircular concentric cutting blade 33 in the circular stapler body 22moves upon actuation by an operator from a retracted position to anextended position to cut through the opposing walls of both the proximal25 and distal 27 colon sections as well as the buttresses 12 placedinternally in each colon section after the staples have been positionedand ejected. The generally circular concentric cutting blade cutsthrough the tissue adjacent to the inner diameter of the innermost rowof staples to allow a continuous lumen to form between the now-joinedcolon sections. Therefore an anastomotic junction is created in the bodytissue. After the anastomotic junction has been formed, the stapler isoperated so that the stapler anvil head 16 is moved away from the staplebody 22 to release the tissue compressed between the compressionsurfaces of the anvil head 18 and stapler body 20. The circular stapler10 is withdrawn transanally carrying with it the sections of colontissue and central regions of the buttresses 12, which were cut by thegenerally circular stapler blade.

FIGS. 2D and 2E show the proximal 24 and distal 26 colon sections nowjoined together. The staples 35, which are located circumferentiallyaround the colon tissue, are held securely in place by means of thecolon tissue walls, 25, 27 which have been reinforced with thebuttresses 12. The buttresses 12 provide circumferential support to theanastomotic junction in addition to enhancing sealing between thestaples and tissue. These buttresses 12 may therefore augment resistanceto radial distension at the anastomotic junction.

The above description relates to use of the buttresses 12 of the presentinvention in forming a tissue anastomosis in a colon resection. It isanticipated that buttresses of this design could be used for othergastrointestinal applications, vascular applications and otherapplications in the human or animal body. Additionally, the abovedescription describes the buttresses 12 both being placed internallywithin the colon segments. In an alternative use, a buttress 12 could beplaced external to the colon segments. Further, buttresses 12 could beplaced internally within each colon segment while another buttress couldbe placed externally between the colon segments. In another use, onebuttress could be placed internally within one colon segment whileanother buttress could be placed externally between the colon segments.The number of buttresses 12 used and placement of the buttresses 12 inand around the relevant tissue sections is left to the surgeon.

The buttress 12 of the present invention may be fabricated from eitherbioabsorbable or non-absorbable biocompatible materials. These materialsmay be either hydrophilic or hydrophopic or rendered hydrophilic orhydrophobic by using an appropriate coating or imbibing process. Forexample, a normally hydrophobic material may be rendered hydrophilicusing a coating of polyvinylalcohol crosslinked on the surface of thematerial. A preferred embodiment for the buttress of the presentinvention is a bioabsorbable ABA triblock copolymer of 67% PGA:33% TMC(w/w) formed into a self-cohering non-woven web as generally taught byHayes in U.S. Pat. Nos. 6,165,217 and 6,309,423. Alternatively, this webor other buttress constructs may be fabricated from other biocompatiblebioabsorbable polymers and copolymers composed from varying amounts ofone or more of the following monomer examples: glycolide, d,l-lactide,l-lactide, d-lactide, p-dioxanone (1,4-dioxane-2-one), trimethylenecarbonate (1,3-dioxane-2-one), e-caprolactone, gamma.-butyrolactone,delta.-valerolactone, 1,4-dioxepan-2-one, and 1,5-dioxepan-2-one. Otherpolymeric constituents of a bioabsorbable copolymer may includepolyethylene glycol, polypropylene glycol, amino acids, anhydrides,orthoesters, phosphazines, amides, urethanes, and phosphoesters.Alternative copolymers may possess, in whole or in part, block,segmented, random, alternating, or statistical polymeric constructioncharacteristics. Animal derived products such as elastin, collagen ordecellularized submucosa, either absorbable (e.g. enzymatically degradedwithin the body) or rendered non-absorbable through chemical treatment(e.g., glutaraldehyde cross-linked bovine pericardium or porcinepericardium), may alternatively be utilized to provide a buttressconstruct. Various non-absorbable polymers may be utilized for buttressconstruction include but are not limited to polytetrafluoroethylene,fluorinated ethylene propylene (FEP), fluoroelastomers, polyurethanes,polyesters (e.g. polyethylene terephthalate), polyacrylamide,polyacetate, polypropylene, polydimethylsiloxane, and nylon. Of these,porous expanded polytetrafluoroethylene (ePTFE), generally made astaught by U.S. Pat. No. 3,953,566 to Gore, may provide a preferrednon-absorbable buttress.

A preferred method of forming the buttress 12 using a bioabsorbablematerial is using a piece of 67%/33% PGA:TMC (w/w) that has been formedinto a self-cohering non woven web into a thickness of approximately0.25 mm following methods as generally taught by Hayes in U.S. Pat. Nos.6,165,217 and 6,309,423. This piece of self-cohering non woven web iscut, for example, by a laser into a generally circular shape with anouter diameter made to coincide with the compression surface outerdiameters for the anvil 18 and body 20 of a particular circular stapler.A variety of other cutting methods, such as die cutting, can bealternatively used. Due to the porous construction of the self-coheringnon-woven web, various bioactive agents and carrier materials can beintroduced into the porous interfiber interstices of the web or coatedonto the fiber strands. Bioactive agents in this context refers togrowth factors, chemotactic factors, morphogens, pharmaceuticals ordrugs, catalysts, proteins, peptides or other biologically activemolecules or genetically altered or native state living cells ofautogenic, allogenic, xenogenic or recombinant origin that induce anintended biological response. Such substances include, but are notlimited to antibiotics, organic or inorganic antimicrobials, healingfactors, blood clotting agents, anticoagulants, antithrombotics,antispasmodics, immunosuppressives, antacids, acid inhibitors, and ulcertreating agents. Other fillers can include radiopaque substances toenhance visualization. Bioactive agents and fillers could be used withother porous and non-porous constructions for other bioabsorbable aswell as non-absorbable materials.

FIGS. 3A-3E show top views of buttresses 12 with various relief featurescut into them. These relief features form “adaptive openings” in thereinforcement material. These “adaptive openings” allow a largerdiameter anvil 16 of a circular surgical stapler 10 to be pulled throughthe smaller diameter opening created by the cutting blade of thecircular stapler without causing substantial permanent alteration to thereinforcement material. The relief features are preferably formed bylaser cutting, although they could be made by a variety of other methodssuch as by use of a cutting die. The relief features are sized andplaced so that some part of them remain on the portion of the buttress12 that remains in the patient after the cutting action of the blade ofa circular stapler. As will be further described, an adaptive openingmay also be provided by making the perimeter of the adaptive openingcorrugated, thereby providing extra material along the perimeter andaccordingly increasing its flexibility in order to allow the stapleranvil to be withdrawn through the adaptive opening.

FIG. 3A shows the top view of a buttress 12 with twelve equally spacedlinear radial cuts 32 emanating from the area of a central opening 15.

FIG. 3B shows the top view of a buttress 12 with four equally spacedlinear cuts or slits 34 in a radial spoke type pattern emanating fromthe area of a central opening 15.

FIG. 3C shows the top view of a buttress 12 with four equally spacedlinear cuts or slits 34 surrounding a central opening 15 as in FIG. 3Bbut with the addition of four radial cuts or slits 36 originating fromthe perimeter of the buttress 12.

FIG. 3D demonstrates that the relief features can be other than straightlines. FIG. 3D shows the top view of a buttress 12 that has serpentineshaped relief features 48 emanating from the area of a central opening15.

FIG. 3E demonstrates that other geometric figures could provide similarfunction to the operation of the buttress, showing the top view of abuttress 12 with a series of generally triangular shapes 40 that arearranged radially around a central opening 15. The bases of thetriangular shapes 42 are placed to coincide with the outside diameter ofthe generally circular concentric cutting blade of the selected circularstapler.

FIG. 3F shows a top view of a buttress 12 having a slit 51 through theentire width. It is apparent that, in addition to providing for anadaptive opening, the slit 51 allows the buttress 12 to be fitted overthe central shaft 14 of the stapler without necessitating the priorremoval of the anvil 16 from the stapler body 22.

FIG. 3G is a perspective view of a buttress 12 showing an embodimentwherein the adaptive opening results from corrugations 54. FIG. 3G hasan inner edge 50 and an outer edge 52 with corrugations 54 that areformed between the inner and outer edges 50, 52. These corrugations maybe made, for example, by transversely cutting a short segment from alength of tubular material, and deforming the resulting ring-shapedsegment by bending one edge inwardly to cause the inner hole whereby theextra material results in corrugations. Alternatively, a mold could beused to form the corrugations.

FIG. 3H is a perspective view of a buttress 12 showing an embodimentwherein the adaptive opening results from corrugations 54. FIG. 3H hasan inner edge 50 and an outer edge 52 with corrugations 54 that arepresent at the outer edge 52 but not at the inner edge 50. In analternate embodiment, the corrugations could be formed at the inner edge50, but not at the outer edge 52.

FIG. 3J is a perspective view of a buttress 12 showing an embodimentwherein the adaptive opening results from corrugations 54. FIG. 3J has acentral non-corrugated or planar region 56 with a corrugated area fromthe outer perimeter of the corrugated or planar region 58 to the outeredge of the buttress 52.

FIG. 3K is a perspective view of a buttress 12 showing an embodimentwherein the adaptive opening results from corrugations 54 of the innerregion of the buttress. FIG. 3K has an outer non-corrugated or planarregion 78 that surrounds the central region having corrugations 54.

In each of the buttresses depicted in FIGS. 3G, 3H, 3J, and 3K, theadaptive opening resulting from corrugations 54 are sized and placed sothat some part of the adaptive opening remains on the portion of thebuttress 12 that remains in the patient after the cutting action of theblade of a circular stapler.

It is anticipated that designs other than those depicted in FIGS. 3A-3H,3J and 3K may be used for the relief features on the buttresses 12.These various relief features allow for the anvil head 16 of a circularstapler 10 to pass through a buttress 12 without tearing orsubstantially altering the buttress 12, even though the anvil head 16compression surface 18 has an outer diameter larger than the innerdiameter of the hole formed in the buttress 12 when a generallycircular, concentric cutting blade of the circular stapler 10 has beenused to cut the hole in the buttress 12.

Self alignment of the buttress 12 onto a circular surgical stapler isanother important aspect of this invention. Self alignment insures thatthe buttress is generally aligned to coincide with and cover the patternof staples ejected from the stapler. The buttress 12 may be self-alignedusing an opening in its central region sized to closely fit the centralshaft of a circular stapler with which it is used. Alternatively, thebuttress 12 may be self-aligned using the outer diameter of the stapleranvil compression surface 18 and the outer diameter of the stapler bodycompression surface 20. FIGS. 3A-3H, 3J, 3K, 6A and 6B show buttresses12 adapted to self align using openings in their central regions. FIG.6A shows a perspective view of a buttress 12 which has an openingfeature 61 in its central region. FIG. 6B shows a cross section of thebuttress shown in FIG. 6A. Surface 60 in FIG. 6B contacts the outerdiameter of the central shaft 14 (FIG. 1B) of a circular stapler 10.FIG. 6C shows a perspective view of a buttress 12 which is adapted toself align onto the outer diameter of the stapler anvil compressionsurface 18 (FIG. 1B) or outer diameter of the stapler body compressionsurface 20 (FIG. 1B). FIG. 6D shows a cross section of the buttressshown in FIG. 6C. Surface 62 in FIG. 6D contacts the outer diameter ofthe stapler anvil compression surface 18 (FIG. 1B) or outer diameter ofthe stapler body compression surface 20 (FIG. 1B) to insureself-alignment.

The buttress 12 can be made of a constant thickness or can be made ofvarying thickness, densities or materials of construction through theircross sections. Varying thicknesses, densities or materials ofconstruction can be of advantage in some embodiments. For example,greater thickness or use of a denser material in the central region ofthe buttress would add rigidity, potentially aiding in self-aligning ofthe buttress 12 on the circular stapler 10. Thickness, density ormaterial variations may also help to prevent deformation of the buttress12 as the circular stapler is used in the process of pulling the stapleranvil 16 toward the stapler body 22 (as depicted in FIGS. 2B and 2C).This thicker or higher density material could be limited to the centralregion of the buttress so that the generally circular concentric cuttingblade of the stapler 10 would cut through or around this thickermaterial and remove it while the stapler was being withdrawn. In anotherembodiment, thinner or less dense material could be made to generallycoincide with the cutting diameter of the generally circular concentriccutting blade of the selected circular stapler to facilitate the cuttingprocess. Alternatively, thicker, more dense or stronger material couldbe constructed into the buttress 12 so as to coincide with the areaswhere the staples are placed with thinner, less dense or weaker materialused in other areas.

Three embodiments of buttresses 12 of varying cross sections are shownin FIGS. 4A-4C. FIG. 4A shows the side view of a buttress 12 that has asilicone disk 36 attached to it. The silicone disk 36 may beapproximately 0.5 mm thick, made, for example, with Nusil MED 4080(NuSil Technology, Carpinteria, Calif.) and can be provided with centerhole sized to form a slight interference fit with the central shaft 14of a circular stapler 10. The interference fit between the central shaft14 of the stapler and the center hole in the silicone disk 36 providesfor a means to securely fasten the buttress 12 to the circular staplerwithout an adhesive. The outer diameter of this silicone disk 36 issized to correspond with the central region of the buttress 12, fittingwithin the diameter of the generally circular concentric cutting bladeof a circular stapler 10.

One side of the silicone disc 36 is adhered to one side of the buttress12 by covering one side of the disc 36 with a thin coating of a pressuresensitive adhesive formulation of silicone (e.g., NuSil MED 1356, NuSilTechnology, Carpinteria, Calif.). After a 30 minute drying period, disc36 may be placed onto one surface of buttress 12 with the adhesivecoated surface of the silicone disk 36 facing towards the surface of thebuttress 12 as illustrated in FIG. 4A. Compressive force is then appliedto the silicone disk 36 to assure adequate bonding between of thesilicone disk 36 to the buttress 12.

Other means of making the central section of the buttress 12 thicker maybe used, such as using materials other than silicone or building up moreself-cohering non-woven web thickness.

FIG. 4B shows the side view of a buttress 12 where the central region 37is thicker due to the process of adding more material to the centralregion in comparison to the thickness adjacent the perimeter. FIG. 4Cshows the top view of a buttress 12 where the central section 42 is madewith thicker or higher density material. Spokes 44 emanating from thecentral section 42 are also made with thicker or higher densitymaterial. A perimeter area 46 of the buttress 12 as depicted can also bemade with a thicker or higher density material to increase the strengthof the material for staple reinforcement. The buttresses 12 depicted inFIGS. 3A-3E and 4A-4C and other designs that can be contemplated mayalso be constructed in a modular fashion such that individual materialscan be combined to form the final device.

Additionally, buttresses 12 of various designs including those depictedin FIGS. 3A-3H, 3J, 3K, and 4A-4C can be used with a circular staplerthat has a round or non-round central shaft. Circular staplers withnon-round shafts with buttresses 12 having central openingscorresponding to the shape of the shaft could facilitate indexing of thebuttresses 12 to locations relative to the stapler anvil and bodycompression surfaces 18 and 20.

FIGS. 7A, 7B, 7C, 8A and 8B depict a preferred embodiment used toself-align and securely attach buttresses 12 to a circular stapler body22 and/or to a circular stapler anvil 16. FIG. 7A shows a perspectiveview of a buttress 12 with four removable protrusions 80 extending fromthe perimeter of the buttress. The removable protrusions 80 are coatedon one side with an adhesive substance that covers only the surfaces ofthe protrusions and not the buttress. The adhesive substance coated onone side of the protrusions 80 is covered by removable coverings 82 thatprotect the adhesive substance from inadvertent contact. Removablecoverings 82 are shown in FIG. 7A as being only adhered to the sides ofthe protrusions 80 which are coated with adhesive, but not to thebuttress 12, which has no adhesive on it. The portions of the removablecoverings that overlap the buttress 12 are not adhered to the buttress12 allowing for tab sections 86 that are easily grasped when removal ofthe coverings 82 is desired. FIG. 7B shows a top view of a buttress 12with four protrusions 80 extending from the perimeter of the buttresswith one removable covering 82 having been removed revealing disruptablesections 84 between the protrusion 80 and the perimeter of buttress 12.The disruptable sections 84 between the perimeter of buttress 12 and theprotrusions 80 may be disrupted after the buttress 12 is attached to theanastomotic junction formed when staples are fired through the buttress12 and tissue of the patient by the circular stapler and then thecircular stapler is subsequently withdrawn from the patient allowing theprotrusions 80 to detach from the buttress 12. The protrusions 80 afterdisruption at disruptable sections 84 stay attached to the circularstapler body 22 and/or circular stapler anvil head 16 while the buttress12 remains in the tissue of the patient at the anastomotic junction thatis formed. Alternatively, the disruptably attached protrusions, 80 maybe detached from the buttress 12 at any other time by the operator ifdesired. FIG. 7C shows a cross-sectional view of a buttress 12 withprotrusions 80 connected with disruptable sections 84 to the perimeterof the buttress. The protrusions 80 have an adhesive 88 between theprotrusion 80 and the removable covering 82. A tab section 86 of eachremovable covering overlaps the buttress 12 but is not attached toeither the buttress or to the protrusion 80. This unattached tab section86 of the removable covering 82 can be used to grasp the removablecovering 82 to facilitate its removal by the user.

FIG. 8A shows a front view of a circular stapler anvil head 16 with abuttress 12 in position to be attached to the circular stapler anvilhead using protrusions 80 from which removable coverings 82 have beenremoved. The protrusions 80 are covered with an adhesive substance ononly the side of the protrusions which will contact the anvil head whenthe protrusion is positioned to conform to the contours of the anvilhead. FIG. 8B shows a buttress 12 attached to a circular stapler body 22with protrusions 80 from which removable coverings 82 have been removed.These protrusions 80 are coated on one side only with an adhesivesubstance 88. The adhesive substance 88 contacts the circular staplerbody 22 when the protrusions 80 are positioned to conform to thecontours of the outer surface of the circular stapler body 22. Althoughfour protrusions are shown attached to buttresses 12 in FIGS. 7A, 7B,and 7C, other numbers of protrusions may also be used. Additionally, theprotrusions may be made in other lengths, widths or geometric shapesthan those depicted. Also, the protrusions may be provided withoutadhesive should it be desired to secure the buttresses 12 to thecircular stapler through other means, such as, for example with asuture, adhesive tape, or adhesives applied to the protrusions at thetime of use. Alternatively, the removable coverings 82 may be left onthe protrusions 80 should it be desired to not use the adhesivesubstance 88 to adhere the protrusions to the stapler body surfaces.Further, the protrusions 80 may be removed from the buttress 12 at anytime by the operator should the operator deem the removal of theprotrusions 80 from the buttress 12 to be more favorable to theprocedure which is contemplated by the operator.

A buttress 12 can be constructed to exhibit either essentially elasticor essentially inelastic behavior. Essentially elastic behavior occurswhen a buttress 12 is adequately deformable so as to allow an anvil head16 of larger outer diameter to pass through the smaller diameter openingformed in the buttress 12 by the circular stapler cutting blade withoutcausing permanent alteration or damage to the cut edge of the openingformed by the cutting action of the circular stapler blade. Permanentalteration of the cut edge results from tears, rips, or other permanentdeformation. Essentially inelastic behavior occurs when an anvil head 16of larger outer diameter than the smaller diameter opening formed in abuttress 12 by the circular stapler cutting blade causes permanentalteration or damage to the cut edge of the opening formed by thecircular stapler cutting blade. The essentially inelastic buttress 12 bydefinition would rip, tear, or otherwise retain permanent alteration tothe cut edge of the opening formed by the circular stapler cutting bladeafter passing the larger diameter anvil head 16 through the smalleropening formed by the circular stapler cutting blade. A buttress may bemade from either relatively elastic (e.g., silicone) or relativelyinelastic materials (e.g., PGA:TMC). If made from relatively inelasticmaterials, the buttress may be fabricated in such a way as to nowpossess essentially elastic behavior. For example, inelastic materialsmay be fabricated into a material possessing a degree of porosity, suchas a weave or a web, wherein the porosity provides for adequateflexibility thereby allowing the resulting buttress to demonstrateessentially elastic behavior.

The relief features shown in FIGS. 3A-3H, 3J and 3K as well as otherscan be used with either essentially elastic or essentially inelasticbuttresses 12. These relief features will be required, however, forbuttresses 12 that without such relief features would exhibitessentially inelastic behavior.

FIG. 5A shows the top view of a buttress 12 which has a central opening15 sized to closely fit the outside diameter of a central tubular shaft14 of a circular stapler 10. FIG. 5B shows the top view of a buttress 12after a hole with a cut edge 38 has been cut through it by the action ofa generally circular concentric cutting blade of a circular stapler 10.FIG. 5C shows the top view of a buttress 12 constructed to be elasticafter a circular stapler anvil head 16 with a compression surface 18that has an outer diameter larger than the diameter of the cut edge 38of the opening formed by the action of a generally circular concentriccutting blade has been passed through it. No substantial permanentalteration or damage is made to the cut edge 38 of the opening formed bythe generally circular concentric cutting blade of the circular stapler.

FIGS. 5D, 5E and 5G show the top and side views of buttresses 12 thatare inelastic and without relief features such as shown in FIGS. 3A-3H,3J and 3K, after pulling through a circular stapler anvil head 16 with acompression surface 18 that has an outer diameter larger than thediameter of the cut edge 38 of an opening formed by the action of agenerally circular concentric cutting blade. These buttresses 12 showsubstantial permanent alteration or damage to the cut edge 38 area ofthe opening formed by the action of a generally circular concentriccutting blade of a circular stapler 10. FIG. 5D of an inelastic buttress12 shows tears 48 around the cut edge 38 of the opening caused bypulling through a circular stapler anvil head 16 with a compressionsurface 18 that has a larger diameter than that of the opening. FIGS. 5Eand 5G of an inelastic buttress 12 show deformation 49 around the cutedge 38 of the opening caused by pulling through a circular stapleranvil head 16 with a compression surface 18 that has a larger diameterthan that of the opening. Other modes of substantial permanentalteration or damage of the cut edge 38 can be contemplated.

EXAMPLES Example 1

In order to evaluate the compatibility of buttresses of the presentinvention with circular staplers, two buttresses of 67% PGA:33% TMC(wtw) having a web density of about 0.5 g/cc were made. These buttresseswere made to have a circular shape with an outside diameter ofapproximately 30 mm, for use with a circular stapler (ILS 29 mm, EthiconEndosurgery, Somerville N.J.). The buttresses were of uniform thicknessof about 0.25 mm, and were provided with a center hole of about 6.3 mmdiameter. The central region of each buttress was also provided with acircular silicone stiffener having a diameter of about 19.1 mm and athickness of about 0.5 mm. Each of these stiffeners was provided with a6.3 mm diameter hole at its center. One stiffener was adhered to oneside of each buttress with the center holes through each componentaligned, using MED-1356 silicone adhesive, Nusil technologies,Carpenteria Calif.

A 30 cm section of porcine colon was obtained and cut in half; pursestring sutures were made on adjacent ends of the large bowel sections.The anvil, with first buttress in place with the stiffener facing thestapler body, was fed through one section so that the anvil postprotruded through the hole in the purse-stringed end. The stapler body,with the shaft extended and with the second buttress in place with thestiffener facing the anvil, was advanced through the adjacent colontissue until the post protruded through the purse-stringed hole. Theanvil post was mated to the body shaft and closed via the actuator knobon the proximal end of the device according to the manufacturer'sinstructions for use. After firing the stapler and rotating the actuatorknob two full turns, the stapler was rotated 90 degrees relative to theanastomosis in both directions and then removed from the colon tissue,pulling the anvil through the anastomosis. Both sides of the anastomosiswere observed visually for integrity of the buttresses after removingthe anvil (of 28.6 mm outside diameter) through the cut hole (of 20.8 mmdiameter). All staples on both sides of the anastomosis were capturedand no signs of tearing or disfigurement were observed.

An additional pair of buttresses was fabricated and tested in the samemanner. Each buttress of this additional pair was provided with fourslits through the thickness of the material, spaced 90 degrees apart andextending radially outward from a point 1.9 mm from the edge of thecenter hole for a length of 7.6 mm. During testing, this pair wasdetermined to be equally effective as the first pair.

Example 2

A preferred embodiment of a buttress with protrusions was made of 67%PGA: 33% TMC (w/w) having a web density of about 0.5 g/cc. using thefollowing method. Two acrylic sheets, each approximately 1.6 mm thickwere securely taped with duct tape onto a laser table that hadperforations to allow for fume elimination and with a cutting head thatwas motion controlled by computer. The acrylic sheets were cut with alaser (Laser Machining Incorporated, Model C-42, Somerset, Wis.) into afirst pattern as shown in FIG. 9A. A first laser cut was made describingthis pattern followed by a second laser cut in the same pattern toinsure that both acrylic sheets were cut completely through. The lasercut pieces of acrylic material were then removed from the remainder ofthe acrylic sheet which was still attached to the laser cutting table byduct tape.

A piece of double coated medical tape with silicone release coating onboth sides of the bleached Kraft paper covering both sides of the tape(3M, product number 1509, St.Paul, Minn.) was sized to cover the lasercut pattern shown in FIG. 9A was then placed over the pattern cut intothe acrylic sheets which were still securely taped to the laser table.The laser was used to cut through the double coated medical tape andKraft paper covering both sides of the tape in the pattern shown in FIG.9A. The piece of double coated medical tape with Kraft paper coveringboth sides which was cut into the pattern shown in FIG. 9A was thenremoved from the laser table.

Using a sharp razor blade, the Kraft paper on the top side of the doublecoated medical tape was carefully peeled away from the each tab 90 fromthe pattern shown in FIG. 9A to approximately the perimeter of the innerdiameter 92 of the pattern shown in FIG. 9A to expose the adhesive tapeunderneath. The sharp razor blade was then used to score the now exposedadhesive tape at approximately the perimeter of the inner diameter 92 ofthe pattern, taking care to not cut through the bottom layer of Kraftpaper underneath the double coated medical tape. The sharp razor bladewas then used to carefully scrape away the double coated medical tapefrom the bottom layer of Kraft paper from each tab 90 so that the Kraftpaper that was underneath the double coated medical tape in the area ofeach tab 90 was now essentially free of adhesive substance. Afterscraping off the double coated medical tape from each tab 90, the entiretop layer of Kraft paper covering the double coated medical tape wasremoved, now leaving the pattern shown in FIG. 9A with no double coatedmedical tape in the areas of each tab 90, but with double coated medicaltape on the remainder of the pattern surface.

The double coated medical tape with Kraft paper on the bottom side inthe pattern shown in FIG. 9A was then put back onto the laser table andinserted into the cavity left by the pattern that had been cut into theacrylic sheets. The indexing marks 94 which had been cut into theacrylic sheets and the double coated medical tape and Kraft paper wereused to align the double coated medical tape and Kraft paper into thepattern cut into the acrylic sheets. The double coated medical tape andKraft paper pattern was inserted into the cavity left by the patternthat had been cut into the acrylic sheet with the adhesive layer facingup and the now single layer of Kraft paper located between the lasertable and the double coated medical tape.

A layer of 67% PGA: 33% TMC (w/w) material cut large enough to cover thepattern shown in FIG. 9A was then placed onto the exposed adhesive layerof the double coated medical tape on the laser table which allowed the67% PGA: 33% TMC material to adhere to the double coated medical tape.The laser was then used to cut out a second pattern 100 as shown in FIG.9B. After removing the excess 67% PGA:33% TMC material and excess doublecoated medical tape, this process produced the device shown in FIG. 9Cwhich shows a perspective view of a buttress 12 with four removableprotrusions 80 extending from the perimeter of the buttress.

The removable protrusions 80 were covered on one side with the doublecoated medical tape that coated only the surfaces of the protrusions andnot the buttress. The double coated medical tape on one side of theprotrusions 80 was covered by perforated removable coverings 82A thatprotected the adhesive substance on the double coated medical tape frominadvertent contact. Perforated removable coverings 82A as shown in FIG.9C were only adhered to the protrusions 80 which were coated with thedouble coated medical tape, but not to the buttress 12, which had nodouble coated medical tape on it. The tab sections 86 of the perforatedremovable coverings 82A that overlapped the buttress 12 were not adheredto the buttress 12 because the double coated medical tape on these areasof the removable coverings had been removed as described previously.Removal of the double coated medical tape from these areas of theperforated removable coverings 82A allowed for tab sections 86 that wereeasily grasped when removal of the coverings 82A was desired.

Buttresses with various inner and outer diameters were made. Onebuttress 12 made had an inner diameter central opening 15 as depicted inFIG. 9C of approximately 6.3 mm and an outer diameter of approximately30 mm for use with a circular stapler (ILS 29 mm, Ethicon Endosurgery,Somerville, N.J.). Buttresses of other dimensions were made to fitcircular staplers produced by other manufacturers such as the PremiumPlus CEEA circular stapler (United States Surgical/Tyco Healthcare,Norwalk, Conn.).

While the principles of the invention have been made clear in theillustrative embodiments set forth herein, it will be obvious to thoseskilled in the art to make various modifications to the structure,arrangement, proportion, elements, materials and components used in thepractice of the invention. To the extent that these variousmodifications do not depart from the spirit and scope of the appendedclaims, they are intended to be encompassed therein.

1. A reinforcement device for use with a circular stapler that isadapted to create and seal a surgical opening in a patient comprising: abuttress adapted for mounting on the circular stapler, the staplerhaving an anvil that is larger in diameter than the surgical openingthat is created by the stapler, wherein following stapling with thestapler, the buttress reinforces the surgical opening created by thestapler in the patient; wherein the buttress includes at least oneadaptive opening created by the circular stapler which corresponds tothe surgical opening in the patient, said adaptive opening when circularhaving a diameter smaller than the diameter of the anvil, and whereinthe adaptive opening in the buttress allows the anvil to be removedtherethrough without causing permanent alteration to the buttress. 2.The reinforcement device of claim 1 wherein the permanent alterationincludes tearing.
 3. The reinforcement device of claim 1 wherein thepermanent alteration includes permanent deformation to the adaptiveopening created by the stapler.
 4. The reinforcement device of claim 1wherein the buttress has slits along a periphery of the adaptiveopening.
 5. The reinforcement device of claim 1 wherein the buttress iscorrugated along a periphery of the adaptive opening.
 6. Thereinforcement device of claim 1 wherein the buttress self-aligns on thestapler anvil.
 7. The reinforcement device of claim 6 wherein theself-aligned buttress is retained on the stapler without use of anadhesive on portions of the buttress that contact a compression surfaceof said stapler.
 8. The reinforcement device of claim 6 wherein thebuttress self-aligns with respect to a central shaft on the stapleranvil.
 9. The reinforcement device of claim 6 wherein the buttressself-aligns on the stapler anvil by conforming to an edge delimiting anouter diameter of the stapler.
 10. The reinforcement device of claim 1wherein the reinforcement buttress comprises a bioabsorbable material.11. The reinforcement device of claim 10, wherein the bioabsorbablematerial comprises a copolymer of poly(glycolide:trimethylenecarbonate).
 12. The reinforcement device of claim 1 wherein the buttressincludes a filler material.
 13. The reinforcement device of claim 12wherein the filler material comprises a therapeutic agent.
 14. Thereinforcement device of claim 12 wherein the filler material comprises abioactive agent.
 15. The reinforcement device of claim 1 wherein thebuttress comprises an essentially inelastic material.
 16. Thereinforcement device of claim 1 wherein the buttress comprises anessentially elastic material.
 17. The reinforcement device of claim 1wherein the buttress comprises at least one polymeric material.
 18. Thereinforcement device of claim 17 wherein the polymeric materialcomprises polytetrafluoroethylene.
 19. The reinforcement device of claim18 wherein the polytetrafluoroethylene is porous expandedpolytetrafluoroethylene.
 20. The reinforcement device of claim 1 whereinthe circular stapler is adapted to create an anastomotic junctionbetween body tissue; and the buttress augments resistance to radialdistension at the anastomotic junction.
 21. The reinforcement device ofclaim 1 wherein the device has a reinforced central region that providesadded rigidity to the central region.
 22. The reinforcement device ofclaim 21 wherein the central region has greater thickness than otherregions of the device.
 23. The reinforcement device of claim 21 whereinthe central region has denser material than other regions of the device.24. The reinforcement device of claim 1 further comprising at least oneprotrusion disruptably connected to said buttress, said protrusionhaving an adhesive on at least a portion thereof for attaching saidbuttress to said stapler.
 25. The reinforcement device of claim 24further comprising a removable covering placed over said adhesive onsaid protrusion.
 26. A reinforcement device for use with a circularstapler adapted to create a substantially circular hole in a patient,said circular stapler having a stapler anvil portion with a firstcompression surface and a stapler body portion with a second compressionsurface, said reinforcement device comprising: a first buttress having afirst contact surface adapted to attach to said stapler anvil withoutuse of an adhesive on said first compression surface and said firstcontact surface; a second buttress having a second contact surfaceadapted to attach to said stapler body without use of an adhesive onsaid second compression surface and said second contact surface; andwherein the first and second buttresses reinforce said hole created bysaid stapler in said patient when staples are applied.
 27. Thereinforcement device of claim 26 further comprising at least oneprotrusion disruptably connected to said second buttress, saidprotrusion having an adhesive on at least a portion thereof to attachsaid second buttress to said stapler body portion.
 28. The reinforcementdevice of claim 27 further comprising a removable covering placed oversaid adhesive on said protrusion.
 29. The reinforcement device of claim26 further comprising at least one protrusion disruptably connected tosaid first buttress, said protrusion having an adhesive on at least aportion thereof to attach said first buttress to said stapler anvilportion.
 30. The reinforcement device of claim 29 further comprising aremovable covering placed over said adhesive on said protrusion.
 31. Thereinforcement device of claim 26 wherein the stapler includes an anvilthat is larger in diameter than the circular hole that is created by thestapler.
 32. The reinforcement device of claim 26 wherein the buttresscomprises an essentially elastic material.
 33. The reinforcement deviceof claim 26 wherein the buttress comprises an essentially inelasticmaterial.
 34. The reinforcement device of claim 26 wherein the buttresscomprises at least one polymeric material.
 35. The reinforcement deviceof claim 34 wherein the polymeric material comprisespolytetrafluoroethylene.
 36. The reinforcement device of claim 35wherein the polytetrafluoroethylene is porous expandedpolytetrafluoroethylene.
 37. The reinforcement device of claim 26wherein the buttress comprises a bioabsorbable material.
 38. Thereinforcement device of claim 37, wherein the bioabsorbable materialcomprises a copolymer of poly(glycolide:trimethylene carbonate).
 39. Thereinforcement device of claim 26 wherein the buttress includes a filler.40. The reinforcement device of claim 39 wherein the filler includes atherapeutic agent.
 41. The reinforcement device of claim 39 wherein thefiller includes a bioactive agent.
 42. A reinforcement devicecomprising: a circular stapler that is adapted to create a substantiallycircular hole in a patient, said circular stapler having a stapler anvilcompression surface outer diameter, at least one buttress adapted toself align onto the stapler anvil compression surface outer diameter;and wherein the buttress reinforces the hole created by the stapler inthe patient when staples are applied.
 43. The reinforcement device ofclaim 42 wherein the stapler includes an anvil that is larger indiameter than the circular hole that is created by the stapler.
 44. Thereinforcement device of claim 42 wherein the buttress comprises anessentially elastic material.
 45. The reinforcement device of claim 42wherein the buttress comprises an essentially inelastic material. 46.The reinforcement device of claim 42 wherein the buttress comprises atleast one polymeric material.
 47. The reinforcement device of claim 46wherein the polymeric material comprises polytetrafluoroethylene. 48.The reinforcement device of claim 47 wherein the polytetrafluoroethyleneis porous expanded polytetrafluoroethylene.
 49. The reinforcement deviceof claim 42 wherein the buttress comprises a bioabsorbable material. 50.The reinforcement device of claim 49, wherein the bioabsorbable materialcomprises a copolymer of poly(glycolide:trimethylene carbonate).
 51. Thereinforcement device of claim 42 wherein the buttress includes a filler.52. The reinforcement device of claim 51 wherein the filler includes atherapeutic agent.
 53. The reinforcement device of claim 51 wherein thefiller includes a bioactive agent.